Setbacks

Cerecor blasted as its second clinical roll of the dice in days comes up snake eyes

Uli Hacksell, Cerecor

Uli Hacksell, Cerecor

Just a few days after Cerecor was pummeled $CERC by the news that its lead depression drug, CERC-301, failed a mid-stage study, the microcap company has been forced to admit that its top drug overall flopped in a Phase II for nicotine withdrawal.

CERC-501, recently the subject of some considerable market buzz after a similar treatment from Alkermes scored positive data in two late-stage trials, failed the trial of 71 heavy smokers. But the biotech now plans to soldier on in major depression, looking to see if it can make progress in a field littered with the corpses of dead drug programs.

Cerecor’s already battered shares plunged 43%, dropping into penny stock territory in pre-market trading.

“There is preclinical and recent clinical evidence that strongly support the potential use of other KOR antagonists as novel medicines for the treatment of mood- and stress-related conditions, such as MDD and anxiety disorders. We believe that our KOR antagonist, CERC-501, has similar potential,” added Dr. Uli Hacksell, President and Chief Executive Officer at Cerecor. “We will now turn our focus to preparing CERC-501 for a Phase 2/3 clinical trial as an adjunctive treatment of MDD in patients with an inadequate response to standard antidepressant therapies. We hope to initiate this trial in the second half of 2017.”


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RAPS Regulatory Convergence 2017